[Federal Register Volume 65, Number 18 (Thursday, January 27, 2000)]
[Notices]
[Pages 4436-4437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1869]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-5333]


Plans to Develop Guidance on Submitting an Archival Copy of an 
ANDA in Electronic Format; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration's (FDA's) Office of Generic 
Drugs (OGD), within its Center for Drug Evaluation and Research, is 
announcing plans to develop guidance on submitting an archival copy of 
a complete abbreviated new drug application (ANDA) in electronic 
format. OGD has encouraged the electronic submission of some types of 
data on a voluntary basis since 1997. However, these submissions are 
not archivable and are made in addition to a complete paper submission. 
OGD plans to expand its electronic data submission program to include 
all parts of the ANDA, so that the archivable electronic submission can 
replace the paper submission as the ANDA of record. OGD is soliciting 
comments from the public on its current program so it can consider 
these comments as it develops guidance for industry on the submission 
of complete, archivable ANDA's in electronic format. A draft guidance 
will be developed and made available for public comment. The ANDA 
electronic submission guidance will be one in a series of guidances the 
agency is developing to enable sponsors to submit archivable regulatory 
submissions in electronic format.

[[Page 4437]]


DATES:  Submit written comments by March 27, 2000. General comments are 
welcome at any time.

ADDRESSES:  Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Copies of the guidance describing OGD's current 
program entitled ``Preparing Data for Electronic Submission of ANDA's'' 
are available on the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit written requests for single copies of the guidance to 
the Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Send one self-addressed adhesive label to assist that office 
in processing your requests. Additional information can be found on the 
Internet at http://www.fda.gov/cder/OGD.

FOR FURTHER INFORMATION CONTACT:  Jonathan D. Cook, Center for Drug 
Evaluation and Research (HFA-358), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5683.

SUPPLEMENTARY INFORMATION:  As part of the Prescription Drug User Fee 
Act, as amended by the Food and Drug Administration Modernization Act 
of 1997, the agency stated its plans to develop and update its 
information management capabilities to allow electronic submissions by 
2002. In the Federal Register of January 28, 1999 (63 FR 4433 and 
4432), the agency announced the availability of two guidances for 
industry entitled ``Providing Regulatory Submissions in Electronic 
Format--General Considerations'' and ``Providing Regulatory Submissions 
in Electronic Format--NDA's.'' These guidances are the first in a 
series of guidances for industry on submitting archivable regulatory 
submissions in electronic format. In the 1999 guidance on general 
considerations, the agency stated that guidance would be forthcoming on 
other submission types, including investigational new drug 
applications, ANDA's, and product licensing applications. As part of 
that effort, OGD is announcing plans to develop guidance on submitting 
an archival copy of an ANDA in electronic format. As soon as a draft 
guidance has been developed, it will be made available for public 
comment.
    OGD has accepted submission of some types of electronic data in 
ANDA's since 1997. During 1998, OGD received 32 electronic submissions 
for bioequivalence data and 44 electronic submissions for chemistry, 
manufacturing, and control data representing 58 distinct ANDA's from 24 
different companies. The OGD program has been voluntary with the paper 
submission serving as the archivable regulatory basis for review 
decisions. OGD plans to expand its electronic data submission program 
to include all parts of the ANDA, so that the archivable electronic 
submission can replace the paper submission as the ANDA of record.
    Submission of an ANDA in electronic format is expected to yield 
many benefits to industry and FDA, including a more consistent 
submission, a more consistent and rapid review, and, in the future, 
reduction in archiving and storage space.
    Electronic data files described in existing agency guidance and in 
more detail on the OGD program's Internet site will form the basis for 
paperless ANDA submissions. ANDA information not contained in the 
structured data submission (e.g., narratives and graphics) will be 
submitted in Portable Document Format (PDF), consistent with agency 
policy recommendations about filing PDF text and other files explained 
in the 1999 general considerations guidance.
    Pending completion of OGD's guidance on submitting archivable 
ANDA's in electronic format and in the absence of archiving capability, 
a complete paper ANDA submission is still required.
    FDA is seeking input from interested parties on its current program 
for submitting electronic data to OGD. The agency would like to 
consider the public's comments as it develops guidance for industry on 
electronic submission of archivable ANDA's. A guidance for industry 
entitled ``Preparing Data for Electronic Submission of ANDA's'' 
describes OGD's current program.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the agency's current program and 
plans to develop guidance for industry on submitting complete, 
archivable ANDA's in electronic format. Two copies of any comments are 
to be submitted, except that individuals may submit one copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is being issued consistent with FDA's good guidance 
practices (62 FR 8961, February 27, 1997), which provides for early 
public participation in the guidance development process.

    Dated: January 11, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-1869 Filed 1-26-00; 8:45 am]
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